For patients with chronic hepatitis B virus (HBV) infection (hepatitis B surface antigen-positive), outcomes following liver transplantation for end-stage liver disease are poor. Recurrent HBV disease is common and associated with decreased liver graft and patient survival (approximately 50% at 5 years). Studies have shown administration of hepatitis B immune globulin (HBIG) in the perioperative and early posttransplant periods could delay or prevent recurrent HBV infection in these transplant recipients.

Intravenous or intramuscular administration of HBIG has become the standard of care for these liver transplant recipients in most liver transplant programs in the United States since mid-1990. Most therapy protocols administer HBIG in high doses (10,000 IU) during the perioperative period and first week after transplantation, with the goal of achieving serum hepatitis B surface antibody (anti-HBs) levels of >500 mIU/mL. Serial levels of anti-HBs are obtained to determine the pharmacokinetics of HBIG in each patient to guide frequency of HBIG dosing.

There is a high degree of variability in HBIG dosage required to achieve desirable serum anti-HBs levels among transplant recipients during the first few weeks to months after transplantation. Patients who were hepatitis B envelope (HBe) antigen positive before transplantation usually require more HBIG to achieve the target anti-HBs levels, especially in the first week after transplantation.

Duration of HBIG therapy varies from 6 months to indefinite among different US liver transplant programs. Protocols providing <12 months of therapy usually combine HBIG with another effective anti-HBV agent such as lamivudine.

See HBV Infection-Monitoring Before and After Liver Transplantation in Special Instructions.

This test is not useful for determining past hepatitis B or immune status after hepatitis B virus vaccination and it does not provide interpretation of the anti-HBs level detected; order HBAB / Hepatitis B Surface Antibody, Qualitative/Quantitative, Serum for those situations.

Individuals who have received blood component therapies (eg, whole blood), plasma, or intravenous immunoglobulin infusion in the previous 3 to 6 months may have false-positive anti-HBs results due to passive transfer of anti-HBs present in these products.

Performance characteristics have not been established for the following specimen characteristics: